Mean Kappa: 0.04 (SD 0.26)
Median Kappa: 0.01 (IQR -0.13-0.19, range -0.4727273-0.6625)
For ICC and SSE calculation, NA is imputed as 3 (compare Loudon 2017 for ICC). SSE = sum((human-gpt)²). Examples: error of 1 in each of the 9 domains: SSE = 9×(1²)= 9; error of 4 in 1 domain: 1×(4²)=16; error of 2 in 5 domains: SSE = 5×(2²) = 20
Mean SSE: 13.49 (SD 6.59)
Median SSE: 13 (IQR 8-17, range 4-35)
Modules: PragMS: 33, PragQoL: 12
All 45 publications sorted by SSE (best at the top, worst at the bottom):
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | 3 | 4 | 4 | 4 | NA | 4 | 5 | 5 |
| ChatGPT | 2 | 3 | 5 | 3 | 4 | NA | 5 | 4 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 5 | 4 | NA | 4 | NA | 5 | NA | NA |
| ChatGPT | 4 | 4 | 4 | 4 | 3 | 4 | 4 | 4 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 3 | 5 | 3 | NA | 3 | 3 | 5 | 5 |
| ChatGPT | 4 | 4 | 3 | 4 | 4 | 4 | 4 | 4 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 4 | 4 | 4 | 5 | 3 | 3 | 3 | 5 |
| ChatGPT | 4 | 4 | 3 | 4 | 4 | 5 | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 5 | 4 | 4 | 5 | 3 | 4 | 5 | 5 |
| ChatGPT | 4 | NA | 2 | NA | 4 | 4 | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | NA | 4 | 5 | 4 | 3 | 3 | NA | 5 |
| ChatGPT | NA | 5 | 5 | 5 | NA | 5 | 4 | 4 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | 5 | 5 | 5 | NA | NA | 4 | 5 | 5 |
| ChatGPT | 5 | 4 | 3 | 4 | 4 | NA | 4 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | 4 | 5 | 4 | 5 | NA | 4 | 5 | 3 |
| ChatGPT | 4 | 4 | 4 | 4 | 4 | 4 | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 5 | 5 | NA | 4 | 4 | 4 | 5 | 4 |
| ChatGPT | 3 | 4 | 2 | 4 | 4 | 5 | 5 | 3 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | NA | 5 | 4 | 5 | 3 | 4 | 3 | 3 |
| ChatGPT | 4 | NA | 3 | 4 | 4 | NA | 4 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | 4 | 5 | 4 | 5 | 4 | 4 | 5 | 5 |
| ChatGPT | 4 | 3 | 4 | 4 | 4 | 5 | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 4 | 5 | 5 | 5 | 5 | 4 | 5 | 3 |
| ChatGPT | 3 | 4 | 3 | 4 | 4 | NA | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | 4 | 4 | 5 | 5 | 3 | 4 | 5 | 4 |
| ChatGPT | 4 | NA | NA | 4 | 4 | NA | 4 | 4 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 4 | 5 | 5 | 5 | 4 | 4 | 5 | 4 |
| ChatGPT | 4 | 3 | 3 | 4 | 3 | 4 | 4 | 4 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | NA | 5 | NA | NA | 4 | 3 | 5 | 5 |
| ChatGPT | 4 | 3 | 3 | 4 | NA | 5 | 4 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 3 | 5 | 5 | NA | 4 | 4 | 5 | 4 |
| ChatGPT | 4 | NA | 4 | 4 | 4 | 5 | 4 | 2 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | 4 | 5 | 2 | 5 | 2 | 1 | 3 | 3 |
| ChatGPT | 2 | 4 | 4 | 4 | 5 | NA | 4 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 5 | 4 | 5 | 5 | NA | NA | 5 | NA |
| ChatGPT | 4 | 3 | NA | NA | 5 | NA | 4 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 5 | 5 | 4 | 3 | 2 | 3 | 5 | 3 |
| ChatGPT | 4 | 4 | 3 | 5 | 4 | 4 | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 5 | 5 | NA | 3 | 3 | 5 | 5 | 2 |
| ChatGPT | 5 | 4 | 5 | 3 | NA | 4 | 2 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 5 | 4 | 4 | 5 | NA | 4 | 5 | 4 |
| ChatGPT | 4 | NA | 4 | 3 | 3 | NA | 2 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 5 | 5 | 5 | 3 | 3 | 4 | 5 | 3 |
| ChatGPT | 4 | 4 | 4 | 4 | 4 | 5 | 4 | 2 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 5 | 4 | 5 | 5 | NA | 4 | 5 | 5 |
| ChatGPT | 4 | NA | 1 | NA | 4 | NA | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 2 | 5 | 4 | 5 | 4 | 4 | 3 | 5 | 3 |
| ChatGPT | 4 | 2 | 2 | 2 | 3 | 2 | 3 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | NA | 5 | 5 | 5 | NA | 3 | 5 | 5 |
| ChatGPT | 4 | 4 | 3 | 4 | 4 | 5 | 4 | 4 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 4 | 4 | 4 | 3 | 5 | 4 | 5 | 5 |
| ChatGPT | 4 | 4 | 3 | 4 | 4 | 5 | 4 | 4 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 5 | 5 | 5 | 5 | 4 | 5 | 5 | 5 |
| ChatGPT | 4 | 3 | NA | 3 | NA | 4 | 4 | 5 | NA |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | NA | 5 | 3 | 4 | NA | 4 | 5 | 5 |
| ChatGPT | 4 | 4 | NA | 5 | 5 | NA | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | NA | 4 | 4 | 4 | 4 | 4 | 5 | 4 |
| ChatGPT | 4 | 5 | 4 | 4 | 4 | NA | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 5 | 4 | 4 | 1 | NA | 4 | 5 | 3 |
| ChatGPT | 4 | 3 | NA | NA | 2 | 4 | 2 | 5 | NA |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 4 | 3 | NA | NA | NA | 4 | 3 | 2 |
| ChatGPT | 4 | 4 | 3 | 4 | 4 | 4 | 4 | 4 | 2 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | 4 | 4 | 5 | 5 | NA | 5 | 5 | 3 |
| ChatGPT | 4 | 4 | 3 | 5 | 5 | NA | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | NA | 5 | 4 | 5 | NA | 5 | 3 | 3 |
| ChatGPT | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | NA | 5 | 5 | 5 | 5 | 4 | 3 | 4 |
| ChatGPT | 5 | 5 | 5 | 5 | 5 | 4 | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | NA | 5 | 5 | 4 | NA | 5 | 5 | 3 |
| ChatGPT | 4 | 4 | 4 | 4 | 4 | NA | 4 | 5 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 4 | 5 | 4 | 5 | 3 | 3 | 3 | 3 |
| ChatGPT | 4 | 5 | 5 | 4 | 4 | 3 | 4 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 4 | 3 | 5 | NA | 5 | 5 | 5 | 5 |
| ChatGPT | 4 | 3 | 3 | 4 | 4 | NA | 3 | 5 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | 5 | 5 | 5 | 4 | NA | 4 | 5 | NA |
| ChatGPT | NA | NA | 5 | 5 | 5 | NA | 5 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | NA | 4 | 4 | NA | 3 | 4 | 5 | NA |
| ChatGPT | 4 | 4 | 3 | 4 | 4 | NA | 4 | 4 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | NA | 4 | 3 | 5 | NA | 3 | 4 | NA |
| ChatGPT | 2 | NA | 2 | NA | 4 | NA | 4 | 2 | NA |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 3 | NA | 5 | NA | NA | NA | 4 | 5 | NA |
| ChatGPT | 4 | 4 | 4 | 4 | 4 | 5 | 4 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 5 | 1 | 5 | 5 | 5 | 3 | 4 | 5 | 4 |
| ChatGPT | 4 | 4 | 4 | 3 | 3 | NA | 4 | 5 | 5 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | 3 | 4 | 4 | 5 | 5 | 3 | 5 | 5 |
| ChatGPT | 4 | 4 | 2 | 4 | 4 | NA | 4 | 5 | 4 |
| eligibility | recruitment | setting | organization | delivery | adherence | followup | outcome | analysis | |
|---|---|---|---|---|---|---|---|---|---|
| Human | 4 | NA | 5 | 5 | 3 | NA | 5 | 3 | 3 |
| ChatGPT | 4 | 5 | 4 | 5 | 5 | NA | 5 | 5 | 5 |
Eligibility:
“People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited.” [quote 1]
“Participants were included who scored >2 on the General Health Questionnaire 12, a measure of psychological distress, or >7 on the anxiety and depression subscales of the Hospital Anxiety and Depression Scale, thus confirming they had low mood.” [quote 2]
The full text provides clear information on the eligibility criteria used for participant selection. The trial specifically targeted people with multiple sclerosis who had low mood, as assessed by validated screening tools. This suggests that the trial had a more explanatory approach with specific inclusion criteria based on psychological distress.
Score: [2]
Recruitment:
“Participants allocated to intervention were invited to attend a psychological adjustment group for six sessions over 12 weeks.” [quote 3]
“The groups were delivered by two Band 5 assistant psychologists, who were supervised by a Band 8a clinical psychologist, experienced in working with people with multiple sclerosis.” [quote 4]
The full text does not provide explicit information on the recruitment process or any additional efforts made to engage with participants beyond inviting them to attend the intervention. However, the use of specific healthcare professionals experienced in working with people with multiple sclerosis suggests that some effort may have been made to recruit participants who would benefit from the intervention.
Score: [3]
Setting:
The full text explicitly states that the trial was conducted in a community setting. This suggests that the trial was conducted in a setting similar to usual care, indicating a pragmatic approach.
Score: [5]
Organisation:
The full text provides information on the organization of care delivery in the intervention arm, indicating that the intervention was delivered by healthcare professionals with specific expertise in working with people with multiple sclerosis. This suggests that the trial may have required additional resources and expertise beyond usual care.
Score: [3]
Flexibility (delivery):
The full text does not provide explicit information on the flexibility in how the intervention was delivered or any specific protocol or monitoring measures. However, the mention of group treatment sessions suggests that there may have been some flexibility in the delivery of the intervention.
Score: [4]
Flexibility (adherence):
Score: [NA]
The full text does not provide information on the flexibility in how participants were required to adhere to the intervention or any measures to improve adherence. This domain is not applicable to the trial as described.
Follow-up:
The full text provides information on the timing of outcome assessments, indicating that participants were followed up at four and eight months after randomization. This suggests that the intensity of measurement and follow-up in the trial was similar to what would be expected in usual care.
Score: [5]
Primary outcome:
The full text does not provide explicit information on the relevance of the trial’s primary outcome to participants. However, the primary outcome of cost effectiveness is likely to be relevant to participants as it directly relates to the impact of the intervention on their healthcare costs.
Score: [4]
Primary analysis:
The full text does not provide explicit information on the inclusion of all data in the analysis of the primary outcome. However, the mention of evaluating the total costs of the intervention, resource use, and medication suggests that the analysis may have included all available data.
Score: [4]
Eligibility:
Recruitment:
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
“Persons with MS (N = 183) with cognitive concerns were randomly assigned to either the 8-week MAPSS-MS intervention or usual care plus freely available computer games.” [1]
“Participants were recruited via physician referral, targeted mailings to persons with MS on the mailing list of the National MS Society, contact with support groups, and notices in MS newsletters and web sites.” [1]
“The majority of participants were female (87%), white (75%), and married (64%).” [2]
Score: [4]
Recruitment:
“Participants were recruited via physician referral, targeted mailings to persons with MS on the mailing list of the National MS Society, contact with support groups, and notices in MS newsletters and web sites.” [1]
“The comparison group received their usual care and a referral to ‘MyBrainGames’, available for free at MultipleScerosis.com.” [2]
“The fact that both groups demonstrated improvements over time underscores the importance that many people with MS place on dealing with their cognitive limitations.” [2]
Score: [4]
Setting:
Score: [3]
Organisation:
“The MAPSS-MS intervention aims to help persons with MS acquire the highest level of cognitive functioning and functional independence.” [2]
“The intervention included eight weekly 2-h group sessions focused on building efficacy for use of cognitive compensatory strategies and lifestyle activities that support cognitive functioning (e.g., sleep and rest, exercise) paired with a home-based computer-assisted cognitive training program.” [2]
Score: [4]
Flexibility (delivery):
“The MAPSS-MS intervention aims to help persons with MS acquire the highest level of cognitive functioning and functional independence.” [2]
“The intervention included eight weekly 2-h group sessions focused on building efficacy for use of cognitive compensatory strategies and lifestyle activities that support cognitive functioning (e.g., sleep and rest, exercise) paired with a home-based computer-assisted cognitive training program.” [2]
Score: [4]
Flexibility (adherence):
Score: [4]
Follow-up:
Score: [4]
Primary outcome:
“The primary purpose of this study was to determine the effectiveness of a novel computer-assisted cognitive rehabilitation intervention MAPSS-MS (Memory, Attention, Problem Solving Skills in MS) in a multi-site trial with persons with MS.” [1]
“The purpose of this study was to test the refined MAPSS-MS intervention in a larger multi-site trial with a six-month follow-up.” [2]
Score: [4]
Primary analysis:
Score: [5]
Eligibility:
Score: [4]
Recruitment:
Score: [4]
Setting:
Score: [3]
Organisation:
Score: [4]
Flexibility (delivery):
Score: [4]
Flexibility (adherence):
Score: [5]
Follow-up:
Score: [5]
Primary outcome:
Score: [5]
Primary analysis:
Score: [5]
Eligibility:
“36 PwMS with EDSS 4–5.5 and unassisted walking have been randomly assigned…” [1]
“The inclusion criteria were: males and females; age 18 to 70; diagnosis of MS (primary or secondary progressive, relapsing-remitting), without relapses in the preceding three months and an Expanded Disability Status Scale (EDSS) score between 4 and 5.5.” [2]
“The exclusion criteria were: other conditions that may affect motor function, impaired cognitive functioning that interferes with the acquisition of the consent to the study.” [2]
The full text provides clear information on the eligibility criteria for the trial. The participants were carefully selected based on specific criteria related to their MS diagnosis, disability level, and absence of other conditions that may affect motor function. The criteria are relevant to the target population and are not overly restrictive. Score: [4]
Recruitment:
The full text mentions that patients were recruited from a specific outpatient clinic at a university hospital. However, it does not provide details on the recruitment process or any additional efforts made to engage with patients beyond their usual care setting. More information is needed to assess the recruitment domain. Score: [NA]
Setting:
The trial was conducted at Ferrara University Hospital, specifically in the Rehabilitation Outpatient Clinic. This suggests that the setting of the trial is a specialized trial or academic center rather than a usual care setting. Score: [2]
Organization:
The full text mentions that a blind evaluator performed assessments and measurements. However, it does not provide information on any additional resources, provider expertise, or organization of care delivery in the intervention arm compared to usual care. More information is needed to assess the organization domain. Score: [NA]
Flexibility (delivery):
The full text describes the task-oriented circuit training (TOCT) intervention, which includes different workstations with varying levels of complexity. This suggests that there is flexibility in how the intervention is delivered, allowing for individualized progression based on the participants’ abilities. Score: [4]
Flexibility (adherence):
The full text describes the home-based task-oriented program, which includes recommendations for exercise sessions and exercises similar to those performed during the supervised phase. This suggests that there is flexibility in how participants must adhere to the intervention, allowing for individualized practice at home. Score: [4]
Follow-up:
“Retention was tested on the whole sample at a 12-weeks follow-up.” [2]
“The 12-weeks follow-up after TOCT was collected in the entire population (n = 36), confirming how the positive effects on the primary outcome measure, the 6MWT, were maintained after the end of treatment (p<0.001).” [3]
The full text mentions that a 12-week follow-up was conducted to assess retention and the maintenance of positive effects on the primary outcome measure. This suggests that the intensity of measurement and follow-up in the trial is similar to what would be expected in usual care. Score: [5]
Primary outcome:
The full text reports the primary outcome measure, which is the 6-minute walking test (6MWT). It also provides evidence of the relevance of the outcome measure to the participants, as the task-oriented program was found to be superior to usual care in improving walking endurance. Score: [5]
Primary analysis:
The full text mentions that an intention-to-treat analysis was conducted, including all outcome measures and handling missing data using the last observation carried forward approach. This suggests that all data were included in the analysis of the primary outcome. Score: [5]
Eligibility:
“Participants were recruited from Danish MS clinics” - [Score: 5]
“For inclusion and exclusion criteria, see Langeskov-Christensen et al.24” - [Score: NA]
“Based on the Z-scores, 37 pwMS (43%) were classified as cognitively impaired” - [Score: 5]
Recruitment:
“Eighty-six participants were recruited from Danish MS clinics” - [Score: 5]
“The PAE group underwent supervised high-intensity PAE for 24 weeks, while the waitlist group continued their habitual lifestyle without commencing PAE” - [Score: 5]
“Exercise adherence was high with 44.8 ± 2.6 completed sessions, corresponding to 93.3 ± 5.4% of the planned sessions” - [Score: 5]
Setting:
“Participants were recruited from Danish MS clinics” - [Score: 5]
“The PAE group underwent supervised high-intensity PAE for 24 weeks” - [Score: 5]
“The waitlist group continued their habitual lifestyle without commencing PAE” - [Score: 5]
Organization:
“The PAE group underwent supervised high-intensity PAE for 24 weeks” - [Score: 5]
“Exercise adherence was high with 44.8 ± 2.6 completed sessions, corresponding to 93.3 ± 5.4% of the planned sessions” - [Score: 5]
“The PAE intervention was well tolerated, with no serious adverse events” - [Score: 5]
Flexibility (delivery):
“Supervised PAE sessions were conducted twice weekly during the 24 weeks, with one continuous and one interval exercise session performed each week” - [Score: 4]
“The session volume increased from 30 to 60 minutes during the intervention while the intensity increased from 65% to 95% of individual maximum heart rate” - [Score: 4]
“Twelve pwMS were unable to adhere with the prescribed intensity of 90%–95% of HRmax during the last 8 weeks of the intervention” - [Score: 3]
Flexibility (adherence):
Follow-up:
“Results at T48 showed that after 24 weeks of self-guided physical exercise, the improvements in cardiorespiratory fitness following PAE disappeared” - [Score: 4]
“Follow-up data at T48 showed broad beneficial within-group effects in the PAE group, potentially caused by learning effects or a long-lasting, but slow, prophylactic effect that continued throughout follow-up” - [Score: 4]
Primary outcome:
Primary analysis:
Note: The scores provided are based on the information available in the full text. Some scores may be subjective and could vary depending on the interpretation of the information.
Eligibility:
Recruitment:
Setting:
Organization:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
“Patients with type 2 diabetes (n=264) selected by a self-administered questionnaire aimed at measuring emotional distress and diabetes-related reduced daily functioning.” [1]
“The eligibility criteria changed from having a mild to moderate depression towards suffering from both emotional distress and interference in their daily functioning due to the burden of diabetes.” [1]
Score: [4] The eligibility criteria for this trial are somewhat pragmatic, as they focus on patients with emotional distress and reduced daily functioning related to diabetes. However, the criteria are still somewhat explanatory as they exclude patients with mild to moderate depression.
Recruitment:
“All the family practices of one regional organisation of GPs (a so-called ‘care group’) in the South of the Netherlands were eligible to participate in the study.” [2]
“From the 3822 patients with diabetes who were sent a screening questionnaire, 264 patients gave informed consent to participate in the trial.” [2]
Score: [4] The recruitment methods used in this trial are somewhat pragmatic, as they involve all eligible family practices and a large number of patients. However, the trial did not use targeted invitation letters or other methods to actively recruit participants, which would have made it more pragmatic.
Setting:
“A regional care group in the Netherlands consisting of 77 family practices.” [2]
Score: [4] The setting of this trial is somewhat pragmatic, as it involves a regional care group with multiple family practices. However, it is not clear if the trial was conducted in other types of settings, such as academic or specialized trial centers.
Organisation:
“PNs in the intervention arm were trained in SMS, whereas PNs in the control arm provided usual diabetes care, conforming to the Dutch guidelines.” [2]
“Financial reimbursement for the extra time spent on SMS was added to the bundled payment arrangement for diabetes care.” [2]
Score: [4] The organization of care delivery in this trial is somewhat pragmatic, as it involves training practice nurses in SMS and providing financial reimbursement for the extra time spent on SMS. However, it is not clear if there were any other changes to the organization of care delivery in the intervention arm.
Flexibility (delivery):
“PNs supported patients in the processes of defining problems and finding solutions themselves, by applying problem-solving and reattribution techniques.” [2]
Score: [4] The flexibility in how the intervention is delivered in this trial is somewhat pragmatic, as it involves supporting patients in problem-solving and reattribution techniques. However, it is not clear if there were any strict protocols or measures to improve compliance.
Flexibility (adherence):
“Patients who experienced problems of daily functioning and emotional health problems were offered consultations for SMS.” [2]
Score: [4] The flexibility in how participants must adhere to the intervention in this trial is somewhat pragmatic, as it involves offering consultations for SMS to patients who experience problems. However, it is not clear if there were any strict protocols or measures to improve adherence.
Follow-up:
“Outcomes were measured at baseline and at 4-month and 12-month follow-ups.” [2]
Score: [5] The intensity of measurement and follow-up in this trial is very pragmatic, as it involves measuring outcomes at multiple time points similar to usual care.
Primary outcome:
“The primary outcome measure was a dichotomised score on a Visual Analogue Scale that measured the perceived effect of diabetes on daily functioning.” [2]
Score: [5] The primary outcome measure in this trial is very pragmatic, as it directly measures the perceived effect of diabetes on daily functioning.
Primary analysis:
“Analyses were performed on an intention-to-treat basis.” [2]
Score: [5] The primary analysis in this trial is very pragmatic, as it includes all available data on an intention-to-treat basis.
Overall, this trial has a somewhat pragmatic design, with scores ranging from 4 to 5 in most domains. However, there is some lack of information in certain domains, such as flexibility in delivery and adherence, which prevents a complete assessment.
Eligibility:
“In the case of asthma, for example, the eligibility criteria in most such trials exclude an estimated 95% of patients with a current diagnosis of asthma, including smokers and those who have “insufficient” bronchodilator reversibility or impaired pulmonary function.” [Explanatory]
“We designed these two pragmatic trials to maximize external validity (applicability or generalizability), with the goal of studying a heterogeneous real-world population.” [Pragmatic]
Score: [3]
Recruitment:
“Patients were responsible for obtaining their own medications, as would occur in real life.” [Pragmatic]
“We considered but rejected the addition of a placebo group when designing the study, since we believe it would have been unethical to assign patients to placebo for 2 years.” [Pragmatic]
Score: [4]
Setting:
“Both trials were conducted in accordance with the protocol.” [Explanatory]
“The study was powered for equivalence in the MiniAQLQ score, with the equivalence boundary set at a 95% CI of less than 0.3 for the MiniAQLQ score (i.e., equivalence was declared if the 95% CI was wholly included between –0.3 and 0.3).” [Explanatory]
Score: [2]
Organisation:
“The primary funder and sponsor (National Coordinating Centre for Health Technology Assessment U.K.) provided input with regard to the study design through its commissioning and monitoring brief but played no role in data collection, analysis, or interpretation; the writing of the article; or the decision to submit the article for publication.” [Pragmatic]
“Practice staffs were asked to provide each patient with a written individualized asthma-action plan.” [Pragmatic]
Score: [4]
Flexibility (delivery):
“Choices of individual drugs and devices were made according to normal clinical practice and British asthma guidelines.” [Pragmatic]
“The protocol discouraged substantial treatment changes between randomization and the 2-month visit.” [Pragmatic]
Score: [4]
Flexibility (adherence):
“Adherence to an LTRA was better than it was to the other drugs in both trials.” [Pragmatic]
“Although such poor and differential adherence potentially reduces assay sensitivity (particularly when coupled with treatment crossover), thus biasing results toward equivalence, both poor and differential adherence rates are realities of real-world prescribing and thus part of the treatment effect.” [Pragmatic]
Score: [5]
Follow-up:
“Data collection and statistical analyses were performed by study personnel who were unaware of the treatment assignments; questionnaire-based data were collected under blinded conditions, and routine practice data (including a history of exacerbations) were extracted with the use of dedicated software.” [Pragmatic]
“Data for asthma-related quality of life and asthma control were available over a period of 21 months for 95% and 96% of the patients in the first-line controller and add-on therapy trials, respectively, which are completion rates higher than those in most long-term asthma-therapy trials.” [Pragmatic]
Score: [5]
Primary outcome:
“Mean improvements over a period of 2 years in both the first-line controller and the add-on therapy trials were substantially greater than the MID for questionnaire scores measuring asthma-related quality of life and asthma control.” [Pragmatic]
“For patients receiving an LTRA or an inhaled glucocorticoid as first-line controller therapy, MiniAQLQ scores were equivalent at 2 months, but at 2 years, these scores did not meet our prespecified criterion for equivalence, since the lower boundary of the 95% CI was –0.35.” [Explanatory]
Score: [3]
Primary analysis:
“The primary effectiveness analysis was an intention-to-treat analysis of the MiniAQLQ score at 2 months (the primary time point) and at 2 years.” [Pragmatic]
“Multiple imputation was used where data were missing.” [Pragmatic]
Score: [4]
Eligibility:
Recruitment:
“Recruited patients (recruitment visit, −1) attended an initial 8-week outpatient-based PR programme conducted in each hospital rehabilitation department.” [Score: 4] The recruitment process involved patients attending an outpatient-based PR program, which is similar to usual care. However, the specific details of the recruitment process are not provided in the full text, making it difficult to assess the level of extra effort made to recruit participants.
“All patients gave written informed consent.” [Score: 5] The use of written informed consent suggests that the recruitment process followed standard ethical guidelines and was likely pragmatic in nature.
Setting:
Organization:
Flexibility (delivery):
Flexibility (adherence):
Score: [NA] This domain is not applicable to this trial as there is no mention of adherence issues or measures to improve adherence.
Follow-up:
Primary outcome:
Primary analysis:
Overall, this trial appears to have a pragmatic design, with some domains scoring higher than others. The eligibility criteria, recruitment process, and primary outcome are aligned with usual care, while the setting, organization, and flexibility of delivery show some differences. The flexibility of adherence domain is not applicable, and the level of flexibility in adherence is not described. The follow-up and primary analysis domains align with a pragmatic approach.
Eligibility:
“Eighty people with Expanded Disability Status scores of 1 to 6.5 participated in this trial.” [1]
“The inclusion criteria were as follows: (1) diagnosed with MS in accordance with the McDonald criteria27; (2) registered at the MS outpatient clinic; (3) living in 1 of 6 selected municipalities; (4) aged 18 years or older; (5) capable of providing signed written informed consent; and (6) EDSS score between 1 and 6.5 (1 = minor disability, 6.5 = able to walk 20 m with or without a walking aid).” [1]
No exclusions based on non-compliance, response to treatment, or risk for primary outcome were mentioned. [NA]
Score: [4]
Recruitment:
“In August 2015, 1 of the MS nurses at the Department of Neurology, Nordland Hospital Trust in Bodø, Norway, sent out invitation letters with a consent form to 160 persons with MS who were registered at the MS outpatient clinic, had EDSS scores of 0 to 7, and lived in 1 of the 6 municipalities included in the study.” [1]
No mention of targeted invitation letters, advertising, or incentives for recruitment. [5]
Score: [3]
Setting:
“The GroupCoreDIST intervention was conducted by 6 physical therapists in 6 municipalities in Norway.” [1]
No mention of specialized trial or academic centers. [5]
Score: [4]
Organization:
“The physical therapists had varied experience (between 7–25 years) and certification (2 had both a master’s degree in neurological physical therapy and were clinical specialists in neurological physical therapy, 1 was a clinical specialist in neurological physical therapy, and 3 were generalists in physical therapy).” [1]
No mention of increased staff levels, additional training, or increased resources. [5]
Score: [4]
Flexibility (delivery):
“The physical therapists individualized the exercises by tailoring them according to each individual’s symptoms, disability level, and general well-being, and they intensified the exercises by increasing number of repetitions, level of difficulty, and/or by adding motor-cognitive dual tasks as movement quality improved.” [1]
No mention of a strict protocol or monitoring. [5]
Score: [4]
Flexibility (adherence):
“Participants in the intervention group were encouraged not to seek any physical therapy other than GroupCoreDIST during the 6 weeks of the intervention.” [1]
No mention of exclusion based on adherence or measures to improve adherence. [5]
Score: [5]
Follow-up:
“Assessments were conducted at baseline and at weeks 7, 18, and 30.” [1]
No mention of more frequent or longer visits, unscheduled visits, or extensive data collection. [5]
Score: [5]
Primary outcome:
“The TIS-NV, which requires quality of movement and cooperation between body segments in dynamic sitting balance,29 detected a short-term improvement of 19% in the intervention group, which we consider a clinically meaningful change.” [1]
No use of surrogate or physiological outcome measures. [5]
Score: [5]
Primary analysis:
“All participants with postintervention test assessment scores were included, although some had missing observations.” [1]
No mention of excluding ineligible participants or including only completers or those following the treatment protocol. [5]
Score: [5]
Eligibility:
Recruitment:
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
Recruitment:
“A total of 120 PwMS were recruited via the Sheffield MS Clinic and flyers/community adverts displayed at the local South Yorkshire MS Society branches.” [Score: 4] The recruitment methods used in this trial include both clinic-based recruitment and community-based advertising. This suggests that some extra effort was made to recruit participants beyond what would be used in usual care, but it is not clear if additional incentives or targeted invitation letters were used.
“Of 349 potential participants who were assessed for eligibility, 120 (34%) were randomised.” [Score: 3] The recruitment rate of 34% suggests that there may have been some challenges in recruiting participants for this trial. However, without more information on the total number of eligible participants and the reasons for non-participation, it is difficult to fully assess the recruitment efforts.
Setting:
“An exercise physiologist supervised the delivery of the intervention but with physiotherapist input during the early stages of the programme.” [Score: 4] The intervention was delivered by an exercise physiologist, which suggests that it was implemented in a specialized setting. However, the involvement of a physiotherapist during the early stages of the program may indicate some flexibility in the setting, potentially allowing for delivery in a more usual care setting.
“During weeks 1–6, participants attended two supervised sessions per week at a university exercise research facility and engaged in one additional self-directed exercise session in their home environment.” [Score: 3] The intervention involved both supervised sessions at a university exercise research facility and self-directed exercise sessions at home. While the university exercise research facility may not be a usual care setting, the inclusion of self-directed exercise at home suggests some flexibility in the setting.
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Score: [NA] This domain is not applicable to this trial as there is no mention of adherence issues or measures to improve adherence.
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
“Inclusion criteria were: age of 18 years or above; BDI score of at least 14 on two consecutive occasions and no treatment from psychologist, psychotherapist or psychiatrist within the last three months.” [Score: 4]
“Exclusion criteria were: poor English language skills or cognitive function (score of less than 24 on Mini Mental State Examination [20]); BDI score of at least 29 on two consecutive occasions; active suicidal ideas; current or life-time diagnosis of psychosis, organic mental disorder or substance dependency; Kurtzke Expanded Disability Status Scale (EDSS) score of 8.5 or above [21]).” [Score: 4]
“Two participants in each arm were lost to follow-up at 21 weeks post-randomisation.” [Score: 4]
Recruitment:
“Recruitment through out-patient clinics was somewhat slower than through screening questionnaire mail-out but the overall recruitment yield was similar.” [Score: 3]
“Our initial aim was to recruit 24 participants between 22 October 2008 and 31 January 2009 (101 days; 7.1 participants/month) with candidates identified by three neurologists working in a single weekly specialist MS clinic (Sheffield Teaching Hospitals NHS Trust).” [Score: 3]
“From the 288 invitation packs given out by Sheffield neurologists in the MS clinic, forms were completed and returned by 63 (21.8%) candidates from which we randomised 13 in 281 days (4.5% recruitment yield), or 1.4 participants per month.” [Score: 3]
Setting:
Organisation:
“No PCT with whom we worked offered advice or support for defining problems on which to work or applying the CBT model to individual problems.” [Score: 4]
“The PCTs delivering CCBT reported that they assumed that patients who were non-adherent and non-contactable beyond two weeks had discontinued treatment and made no further effort to contact them.” [Score: 4]
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
“Key inclusion criteria permitted the participation of men or women ≥18 years of age with confirmed and documented RRMS diagnosis (as defined by the Revised McDonald criteria) (Polman et al., 2011), Kurtzke Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at the screening visit, and, 30 days prior to randomization, a stable neurological condition, relapse-free status, and no use of any corticosteroid or adrenocorticotropic hormone treatment.”
“Key exclusion criteria were previous exposure to GA40, a progressive form of MS or neuromyelitis optica, the use of experimental or investigational drugs, participation in clinical drug studies within the 6 months before screening, recent use of immunosuppressive medications or immunoglobulins/monoclonal antibodies, or previous use of alemtuzumab, cladribine, cyclophosphamide, or mitoxantrone.”
The full text provides clear information on the eligibility criteria for the trial, including the specific inclusion and exclusion criteria. The criteria are well-defined and specific to the target population of patients with RRMS. Based on this information, the trial appears to have a relatively explanatory approach with some exclusions, but overall it seems to be pragmatic.
Score: [4]
“The CONFIDENCE study was a multinational, multicenter, randomized, parallel-group, phase 4, open-label study conducted at 88 study centers in 14 countries (Russia, Poland, Italy, France, Croatia, US [including Puerto Rico], Mexico, Spain, Austria, Turkey, Belgium, Argentina, Germany, and Finland) across different geographic regions.”
“Eligible patients were randomly assigned 1:1 to receive subcutaneous injections of GA40 (n = 431) or GA20 (n = 430). Five scheduled visits at study sites occurred at screening (within 2 weeks prior to baseline), baseline (Month 0), and Months 1, 3, and 6 (end of the core phase). Patients also participated in self-reported, daily at-home MSQ assessments on Days 1 through 7 after the baseline visit.”
The full text provides information on the recruitment process, including the number of study centers and countries involved in the trial. It also mentions the random assignment of eligible patients to the two treatment groups. However, there is no specific information on the recruitment efforts made to engage with patients beyond the standard study visits and assessments.
Score: [3]
The full text provides information on the setting of the trial, which involved multiple study centers in 14 different countries. This suggests that the trial was conducted in a variety of settings, including different healthcare systems and regions. However, there is no specific information on how different the trial setting was from the usual care setting.
Score: [3]
The full text provides information on the adverse event profile of the two treatment groups, indicating that the overall organization of care delivery in terms of safety monitoring and management was similar between the groups. However, there is no specific information on any additional resources, provider expertise, or changes in care delivery organization in the intervention arm compared to usual care.
Score: [4]
The full text does not provide any information on the flexibility in how the intervention is delivered or how it compares to usual care. Therefore, it is not possible to assess this domain.
Score: [NA]
The full text provides information on the adherence to treatment measured using the MS-TAQ questionnaire. It indicates that patients receiving GA40 had greater adherence compared to those receiving GA20. This suggests that the trial had a pragmatic approach with no additional measures to improve adherence or exclusion based on adherence.
Score: [5]
The full text provides information on the follow-up period, which lasted for 6 months. It mentions the scheduled visits at study sites at baseline and Months 1, 3, and 6, indicating the intensity of measurement and follow-up during the trial. However, there is no specific information on the likely follow-up in usual care.
Score: [4]
The full text clearly states the primary outcome of the trial, which is patient-reported medication satisfaction using the MSQ. This indicates that the primary outcome is relevant to participants and focuses on their satisfaction with the intervention.
Score: [5]
The full text provides information on the primary analysis, which was based on the intention-to-treat (ITT) analysis set. This indicates that all randomly assigned participants were included in the analysis, regardless of the treatment they actually received. This approach ensures that all data are included in the analysis of the primary outcome.
Score: [5]
Eligibility:
Recruitment:
“Participants were recruited through a statewide organization providing education and support to people with MS, and a large specialist MS outpatient clinic. Recruitment information flyers were sent by mail to all potential participants registered on the mailing lists of both organizations.” [Score: 3] The recruitment methods used in this trial involve targeted approaches through specific organizations and mailing lists. While this may increase the likelihood of recruiting eligible participants, it may also introduce selection bias and limit the generalizability of the trial to the broader population of people with MS.
“There was good adherence with the training program (92%), compared with the control group’s adherence with the increased attention and social activities program (62%).” [Score: 4] The high adherence rate suggests that the recruitment strategies used in this trial were effective in engaging participants and encouraging their participation in the intervention.
Setting:
Organization:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Overall Score: [3.6]
Eligibility:
“Adults diagnosed with MS were included based on the ability to walk 5 km without rest or use of assistive device.” [1]
“Exclusion criteria were reports to have run 5 km in the preceding 6 months or a relapse occurring in the preceding 3 months.” [1]
“Recruited participants showed only mild walking impairment and likely had high exercise self-efficacy levels as they were willing to engage in an individual community-located running training.” [1]
The eligibility criteria for this trial were relatively strict, as participants had to be able to walk 5 km without rest or use of an assistive device. Additionally, individuals who had run 5 km in the preceding 6 months or experienced a relapse in the preceding 3 months were excluded. The recruitment of participants with mild walking impairment and high exercise self-efficacy suggests a more explanatory approach. Score: [2]
Recruitment:
“pwMS were assigned to the experimental (EXP) or the “waiting list control” (WLC) group prior to baseline testing.” [1]
“Participants had a specific common goal which was to run together on a public event.” [1]
“The addition of two group training sessions with direct supervision by the researchers allowed for expert advice and social interaction and peer support.” [1]
The recruitment process involved assigning participants to either the experimental or control group prior to baseline testing. The common goal of running together on a public event and the inclusion of group training sessions with direct supervision suggest a more pragmatic approach to recruitment. Score: [4]
Setting:
“pwMS were recruited through announcements at REVAL rehabilitation research institute (UHasselt), Flemish MS rehabilitation centers and MS Society, and Move-to-Sport.” [1]
“Participants performed their individual training session simultaneously, while being observed by the project dedicated researcher (MSc exercise physiology and PhD) and master students (rehabilitation sciences and physiotherapy).” [1]
The trial was conducted in various settings, including rehabilitation research institutes, MS rehabilitation centers, and MS Society. Additionally, participants performed their individual training sessions simultaneously while being observed by researchers and students. These factors suggest a more pragmatic approach to the setting. Score: [4]
Organisation:
“Participants received training instructions by email and were asked to train three times weekly according to a personalized training intensity schedule.” [1]
“Participants wore an activity tracker at the waist that registered the intensity of steps per minute.” [1]
“Participants were asked to weekly upload data to allow remote supervision of the training adherence by the research assistant.” [1]
The organization of care delivery in the intervention arm involved providing participants with training instructions via email and using activity trackers to monitor their training intensity. Participants were also required to upload data weekly for remote supervision. These aspects suggest a more pragmatic approach to organization. Score: [4]
Flexibility (delivery):
“pwMS received individualized training instructions during 12 weeks, to be performed in their community aiming to participate in a running event.” [1]
“During the first weeks, training consisted of longer walking bouts, interspersed with short 1′ running bouts. The relative amount of running gradually increased until participants were able to run 5 km without interruption at 12 weeks.” [1]
The intervention involved individualized training instructions that were tailored to each participant’s abilities and aimed to prepare them for a running event. The gradual increase in running volume over the 12-week period suggests a more pragmatic approach to delivery. Score: [5]
Flexibility (adherence):
This domain is not applicable to this trial as there is no compliance issue after consent has been given. Score: [NA]
Follow-up:
“Participants were tested at two time points (0 and 12 weeks).” [1]
“The EXP group completed a 12-week gradual “start-to-run” program in between time points.” [1]
The trial involved follow-up assessments at two time points: baseline and 12 weeks. The 12-week duration of the intervention suggests a more pragmatic approach to follow-up. Score: [4]
Primary outcome:
“The primary outcome measures were physical fitness, walking capacity and perceived ability, functional mobility, and quality of life.” [1]
“Secondary outcome measures were fatigue, cognitive function, brain volumes, and structural connectivity.” [1]
The primary outcome measures of the trial were physical fitness, walking capacity, functional mobility, and quality of life. These outcomes are relevant to participants and suggest a more pragmatic approach to the primary outcome. Score: [5]
Primary analysis:
The trial used an intention-to-treat analysis, which includes all randomized participants in the analysis regardless of adherence to the intervention. This approach suggests a more pragmatic approach to the primary analysis. Score: [5]
Eligibility:
“Participants were clients seen in the multiple sclerosis clinics at Sutherland-Chan School, in which the study was conducted. Clients were provided with information about the clinic by the local chapter of the Multiple Sclerosis Society, and self selected on that basis.” [1]
“Of the fifteen study participants, all had previously received a diagnosis of multiple sclerosis.” [1]
“The clients presented to the clinic with a variety of impairments, including some specifically related to the disease process and others that were primarily musculoskeletal in origin.” [1]
The full text provides information about the eligibility criteria for the trial. Participants were clients with a diagnosis of multiple sclerosis who self-selected to participate in the study. The text also mentions that the clients presented with a variety of impairments related to the disease. Based on this information, the trial seems to have a pragmatic approach to eligibility criteria, as it includes a diverse group of participants who are representative of the target population. Score: [4]
Recruitment:
“Clients attending the clinic were interviewed, and their case histories recorded. The research project was explained, and written informed consent was obtained.” [1]
“The inclusion criterion for the study was a diagnosis of multiple sclerosis, and therefore the spectrum of clinical presentations was broad, as would be expected in this client population.” [1]
The full text does not provide specific information about the recruitment methods used in the trial. However, it mentions that clients attending the clinic were interviewed and provided with information about the research project. Based on this information, it can be inferred that the recruitment process was likely pragmatic, involving the recruitment of participants from the clinic setting. Score: [3]
Setting:
The full text indicates that the trial was conducted in the multiple sclerosis clinics at Sutherland-Chan School. However, it does not provide information about the specific settings within the clinics or whether the trial was conducted in multiple centers. Based on the available information, it is not possible to determine the score for this domain. Score: [NA]
Organisation:
“The treatment plans were approved by the clinical teacher in charge.” [1]
“The teacher also monitored treatment delivery, which involved the application of a variety of techniques appropriate to the client’s needs.” [1]
The full text mentions that the treatment plans were approved by a clinical teacher and that the teacher monitored treatment delivery. This suggests that there was some level of organization and oversight in the delivery of the intervention. However, the text does not provide information about any additional resources, provider expertise, or changes in care delivery organization. Based on the available information, it is not possible to determine the score for this domain. Score: [NA]
Flexibility (delivery):
“Massage therapy is aligned with the wellness paradigm of health and health care, which speaks to a holistic client centered approach to treatment.” [1]
“Accordingly, if the current research was to conform to the requirements of model fit/ecological validity, it was incumbent on the therapists to construct individualized treatment plans recognizing the importance of the client’s physical, psychological and emotional needs.” [1]
The full text suggests that the delivery of the intervention was flexible and individualized, taking into account the needs of each client. This aligns with a pragmatic approach to the flexibility of intervention delivery. Score: [5]
Flexibility (adherence):
The full text does not provide information about the flexibility in how participants must adhere to the intervention. Score: [NA]
Follow-up:
The full text indicates that self-efficacy scores were obtained at multiple time points during and after the treatment series. This suggests that there was a follow-up period to assess the longer-term effects of the intervention. Score: [4]
Primary outcome:
“Self-Efficacy [SE] was the outcome for the study, measured using the Multiple Sclerosis Self-Efficacy survey [MSSE].” [1]
“The MSSE survey measures perception, it can be suggested that higher self-efficacy scores reflect improved mood (i.e. reduced depression, anxiety and stress), and a better ability to cope with and adjust to the disease.” [1]
The full text provides information about the primary outcome measure used in the study, which is self-efficacy measured using the MSSE survey. It also suggests that higher self-efficacy scores reflect improved mood and better coping abilities. Based on this information, it can be inferred that the primary outcome is relevant to the participants. Score: [5]
Primary analysis:
The full text mentions that the data were analyzed on an intention to treat basis, which suggests that all available data were included in the analysis of the primary outcome. Score: [5]
Eligibility:
Recruitment:
Setting:
Organization:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Overall, the trial appears to have a pragmatic design, with a focus on real-world applicability and relevance to participants. The scores for each domain are as follows:
Eligibility: [4]
Recruitment: [4]
Setting: [3]
Organization: [5]
Flexibility (delivery): [4]
Flexibility (adherence): [4]
Follow-up: [5]
Primary outcome: [5]
Primary analysis: [5]
Eligibility:
“Participants were randomised in groups of eight to physiotherapist (PT)-led exercise (n = 80), yoga (n = 77), fitness instructor (FI)-led exercise (n = 86) and they took part in weekly community-based group exercise sessions.” [1]
“Our study participants were referred to the project by themselves, their care-giver, MSI, chartered physiotherapists, neurologists, general practitioners or clinical nurse specialists.” [2]
“Eligible participants were over 18 years of age and had a diagnosis of MS that was confirmed by a consultant physician or neurologist.” [2]
The full text provides information on the eligibility criteria for the trial. Participants were recruited from various sources and had to meet specific criteria, such as being over 18 years old and having a confirmed diagnosis of MS. The eligibility criteria appear to be pragmatic, as they are similar to those that would be used in usual care. Score: [5]
Recruitment:
“Participants were randomised in groups of eight to physiotherapist (PT)-led exercise (n = 80), yoga (n = 77), fitness instructor (FI)-led exercise (n = 86) and they took part in weekly community-based group exercise sessions.” [1]
“Our study participants were referred to the project by themselves, their care-giver, MSI, chartered physiotherapists, neurologists, general practitioners or clinical nurse specialists.” [2]
The full text does not provide specific information on the recruitment methods used for the trial. However, it mentions that participants were referred to the project by various sources, suggesting that recruitment methods were likely pragmatic and similar to those used in usual care. Score: [4]
Setting:
“All interventions took place in groups of eight, for an hour per week, for 10 weeks.” [2]
“They were delivered in community centres such as local gyms, hotels and health centres.” [2]
The full text provides information on the setting of the trial. The interventions took place in community settings, such as local gyms, hotels, and health centers. This suggests that the setting was pragmatic and similar to usual care. Score: [5]
Organisation:
“The PT-led exercise provided was pre-defined.” [2]
“The FI-led classes were not pre-defined, as the aim was to establish whether these classes were effective when encountered by those with MS in the community.” [2]
“The yoga intervention was also not predefined.” [2]
The full text provides information on the organization of care delivery in the intervention arms of the trial. The PT-led exercise was pre-defined, suggesting that it may have required additional resources and expertise compared to usual care. The FI-led classes and yoga intervention were not pre-defined, indicating that they may have been more similar to usual care in terms of organization. Score: [3]
Flexibility (delivery):
“The PT-led exercise provided was pre-defined.” [2]
“The FI-led classes were not pre-defined, as the aim was to establish whether these classes were effective when encountered by those with MS in the community.” [2]
“The yoga intervention was also not predefined.” [2]
The full text does not provide specific information on the flexibility in how the intervention was delivered. However, it mentions that the PT-led exercise was pre-defined, suggesting that there may have been less flexibility compared to usual care. The lack of information on the flexibility of the FI-led classes and yoga intervention makes it difficult to assess this domain. Score: [NA]
Flexibility (adherence):
“All interventions took place in groups of eight, for an hour per week, for 10 weeks.” [2]
“Participants were advised to exercise aerobically in the mode of their choice (walking, cycling, swimming or running), with the aim of exercising for 30 minutes, twice a week, at an intensity of 65% of the heart rate max, or a Borg’s rate of perceived exertion of 11–14.” [2]
The full text does not provide specific information on the flexibility in how participants must adhere to the intervention. However, it mentions that participants were advised to exercise aerobically in the mode of their choice, suggesting that there may have been flexibility in adherence similar to usual care. Score: [4]
Follow-up:
The full text provides information on the follow-up period for the trial. Outcome assessment was conducted at week 24 for the intervention groups only, which suggests that the intensity of measurement and follow-up may have been greater than usual care. Score: [2]
Primary outcome:
The full text provides information on the primary outcome measure used in the trial. The MSIS-29v2 physical component is a patient-reported outcome measure that assesses the physical impact of MS. This suggests that the primary outcome was relevant to participants and similar to what would be assessed in usual care. Score: [5]
Primary analysis:
The full text mentions that all participants were analyzed in the groups to which they were randomized, indicating that an intention-to-treat analysis was likely used. This suggests that all data were included in the analysis of the primary outcome, similar to what would be done in usual care. Score: [5]
Eligibility:
“Patients in South East London who were severely affected by MS were referred by clinicians to the trial.” [Quote 1]
“Inclusion criteria were patients in South East London, living with MS and deemed (by clinicians) to have one or more of unresolved symptoms, psychosocial concerns, end-of-life issues, progressive illness, or complex needs (i.e., palliative care needs).” [Quote 2]
The full text provides information on the eligibility criteria for the trial. Patients with multiple sclerosis (MS) who were severely affected and had unresolved symptoms, psychosocial concerns, end-of-life issues, progressive illness, or complex needs were included. The trial was conducted in South East London and patients were referred by clinicians. Based on this information, the trial appears to have a pragmatic approach to eligibility criteria, as it includes patients who would typically receive palliative care in usual care settings. Score: [4]
Recruitment:
“Patients in South East London who were severely affected by MS were referred by clinicians to the trial.” [Quote 1]
“Educational seminars informed local health and social care professionals about the PCT.” [Quote 2]
The full text mentions that patients were referred to the trial by clinicians and that educational seminars were conducted to inform healthcare professionals about the palliative care team (PCT). However, there is no information provided on any additional recruitment efforts or strategies used to engage with patients beyond the referral process. Without further details, it is difficult to assess the level of effort made to recruit participants. Score: [NA]
Setting:
The trial was conducted in South East London, which suggests that the setting of the trial was similar to the usual care setting for patients in that region. Score: [4]
Organisation:
The full text provides information on the resources and provider expertise available in the intervention arm of the trial. The palliative care team (PCT) consisted of healthcare professionals with expertise in palliative care and the trial was based in a large teaching hospital. This suggests that the trial may have required additional resources and provider expertise compared to usual care. Score: [3]
Flexibility (delivery):
The full text describes the activities of the palliative care team (PCT), which included assessments, providing recommendations for improvement, and offering support and liaison with other services. These activities suggest that there may have been some flexibility in how the intervention was delivered to meet the individual needs of patients. Score: [3]
Flexibility (adherence):
No information is provided in the full text to assess the flexibility in how participants must adhere to the intervention. Score: [NA]
Follow-up:
The full text mentions the follow-up periods for data collection, which were conducted at multiple time points up to 26 weeks. This suggests that the intensity of measurement and follow-up in the trial may have been more frequent and longer than usual care. Score: [2]
Primary outcome:
The primary outcome of the trial was caregiver burden, which is relevant to the participants and their caregivers. The trial focused on improving the well-being of patients and their caregivers, which suggests a pragmatic approach to the primary outcome. Score: [5]
Primary analysis:
The full text mentions that an intention-to-treat analysis was planned, which indicates that all data, including data from ineligible post-randomization participants, were included in the analysis of the primary outcome. This approach aligns with a pragmatic analysis that includes all available data. Score: [5]
Eligibility:
Recruitment:
Setting:
Organization:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Overall score: [3.6]
Eligibility:
Recruitment:
“MS patients from the outpatient clinic of the Neurology Department of Pitié-Salpêtrière Hospital were prospectively enrolled in the study between March 2010 and July 2012.” [Score: 4] The trial recruited patients from a specific outpatient clinic, which may limit the generalizability of the trial to other settings. However, the recruitment process itself does not appear to involve any additional effort beyond usual care.
“Signed informed consent was obtained for each patient at inclusion.” [Score: 5] The trial used standard informed consent procedures, which is consistent with usual care.
Setting:
Organisation:
“For patients in the IMD group, the multidisciplinary integrated outpatient clinic was planned at our MS clinic within a maximum three-month period after inclusion.” [Score: 4] The trial used a multidisciplinary integrated outpatient clinic, which suggests that there may be some differences in the organization of care delivery compared to usual care. However, the specific differences in resources, provider expertise, and organization of care delivery are not clearly described.
“The study protocol was approved by the coordinator of our local (Pitié-Salpêtrière Hospital) ethics committee, and formal review by the committee was judged unnecessary.” [Score: 5] The trial followed standard ethical approval procedures, which is consistent with usual care.
Flexibility (delivery):
Flexibility (adherence):
Score: [NA] This domain is not applicable to this trial as there is no mention of adherence issues or measures to improve adherence.
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
Recruitment:
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Overall, the trial appears to be more explanatory than pragmatic. The scores for each domain are as follows:
Eligibility: [4]
Recruitment: [2]
Setting: [2]
Organisation: [2]
Flexibility (delivery): [3]
Flexibility (adherence): [2]
Follow-up: [3]
Primary outcome: [5]
Primary analysis: [5]
Eligibility:
Recruitment:
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Overall, the trial appears to have a fairly pragmatic design, with some domains leaning more towards the explanatory end of the spectrum. The eligibility criteria, recruitment strategy, and primary outcome measures are all fairly pragmatic, while the setting, organization of care delivery, and flexibility in delivery are somewhat explanatory. The flexibility in adherence and the intensity of follow-up appear to be very pragmatic.
Eligibility:
Recruitment:
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
“Inclusion criteria for the study included (1) a diagnosis of MS, (2) not currently engaged in rehabilitation, therapy or PA program and able to undertake PA without risk-factors (3) aged between 18 and 65 (4) able to give informed consent and to understand French.” [1]
“We excluded those who were receiving drug treatment for fatigue started less than three months ago or acute hospital or nursing home, those who were having psychiatric disorders.” [1]
The full text provides clear information on the eligibility criteria for the study, including the inclusion and exclusion criteria. The criteria are specific and relevant to the target population of people with MS. Based on this information, the trial appears to have a pragmatic approach to eligibility.
Score: [4]
Recruitment:
“Participants were recruited from two hospitals in the Parisian region, in France receiving outpatient services for MS at a regional medical center.” [1]
“Participants were approached by the study coordinator and asked if they would be willing to participate in it.” [1]
The full text provides limited information on the recruitment process. It mentions that participants were recruited from two hospitals and approached by the study coordinator, but it does not provide details on any additional efforts made to recruit participants or any specific recruitment strategies used. Based on the available information, it is difficult to determine the level of effort made to recruit participants beyond what would be used in usual care.
Score: [3]
Setting:
The full text provides information on the setting of the trial, which took place in two hospitals in the Parisian Region. However, it does not provide any details on how the settings of the trial compare to usual care settings. Without this information, it is difficult to assess the level of difference between the trial setting and usual care settings.
Score: [NA]
Organisation:
“The PA program was manualized and available as a booklet.” [1]
“The PA program was delivered by a neurologist and a specialist in physical medicine and rehabilitation.” [1]
The full text provides limited information on the organization of care delivery in the intervention arm of the trial. It mentions that the PA program was manualized and delivered by a neurologist and a specialist in physical medicine and rehabilitation. However, it does not provide details on any additional resources, provider expertise, or changes in care delivery compared to usual care. Based on the available information, it is difficult to assess the level of difference in organization between the intervention arm and usual care.
Score: [3]
Flexibility (delivery):
The full text indicates that the control group did not receive any additional guidance or training beyond the PA program. This suggests that the delivery of the intervention in the control group was similar to usual care, with no additional flexibility or specific protocol. However, the text does not provide information on the flexibility in how the intervention was delivered in the intervention groups compared to usual care.
Score: [NA]
Flexibility (adherence):
The full text provides information on the flexibility in how participants were asked to adhere to the intervention. They were asked to develop if-then plans once a week and share them through an app. This suggests that there was some flexibility in how participants were expected to adhere to the intervention. However, the text does not provide information on any measures to improve adherence or any exclusions based on adherence.
Score: [4]
Follow-up:
The full text provides information on the follow-up period, which was 8 weeks after the intervention. This suggests that the intensity of measurement and follow-up in the trial was similar to usual care, with no additional visits or measurements beyond what would typically be done. However, the text does not provide details on the specific measurements and follow-up procedures used.
Score: [4]
Primary outcome:
The full text provides information on the primary outcomes of the trial, which include fatigue, mobility, and quality of life. These outcomes are relevant to participants and are commonly assessed in MS trials. However, the text does not provide information on any use of surrogate or physiological outcomes, central adjudication, or assessment expertise that is not available in usual care.
Score: [5]
Primary analysis:
The full text provides limited information on the primary analysis of the trial. It mentions the use of the Wilcoxon signed rank test to assess differences in change scores across the three groups for the MSIS-29 physical component. However, it does not provide information on the inclusion of all available data in the analysis or any exclusions or restrictions in the analysis.
Score: [NA]
Eligibility:
“MS patients older than 18 years who had a confirmed MS with spasticity of the lower limbs and an Expanded Disability Status Scale (EDSS) between 4 and 6.5 were eligible for inclusion.” [1]
“Patients who had received hippotherapy within the last 12 months, a body weight over 90 kg, no balance while sitting, and acute exacerbation during the 4-week period before start of the therapy were excluded.” [1]
“A planned start of treatment with new anti-spastic drugs or other medications that may have an influence on the assessed outcomes also resulted in exclusion.” [1]
The eligibility criteria for this trial appear to be relatively pragmatic. The inclusion criteria are specific to MS patients with spasticity of the lower limbs and an EDSS score between 4 and 6.5. The exclusion criteria are reasonable and do not appear to overly restrict the participant population. Overall, the trial seems to have a pragmatic approach to participant eligibility.
Score: [4]
Recruitment:
The recruitment process is not described in detail in the full text. However, it is mentioned that 70 adults with MS were recruited in five German centers. The recruitment process does not appear to involve any additional efforts beyond what would be used in usual care. Therefore, it can be considered relatively pragmatic.
Score: [4]
Setting:
The trial was conducted at five sites in Germany, which suggests a relatively pragmatic choice of settings. However, it is not clear if these sites are representative of usual care settings for MS patients. Without further information, it is difficult to fully assess the setting domain.
Score: [NA]
Organisation:
The trial appears to have a pragmatic approach to the organization of care delivery. The control group continued their previous therapy, and there were no changes to symptomatic drug treatment, immunotherapy, and physiotherapy in either group. This suggests that the trial used resources and care delivery methods that are consistent with usual care.
Score: [5]
Flexibility (delivery):
The intervention group received hippotherapy once a week for 12 weeks as an add-on therapy to their standard care, which remained unchanged. This suggests a relatively pragmatic approach to the delivery of the intervention, as it aligns with usual care practices.
Score: [5]
Flexibility (adherence):
Score: [NA]
Follow-up:
The trial had follow-up assessments at baseline, after 6-7 weeks, and after 12 weeks. This suggests a pragmatic approach to the intensity of measurement and follow-up, as it aligns with usual care practices.
Score: [5]
Primary outcome:
The primary outcome of the trial, the change in the Berg Balance Scale after 12 weeks, appears to be relevant to participants. The BBS is a measure of balance function, which is likely important to MS patients. Therefore, the trial can be considered relatively pragmatic in terms of the primary outcome.
Score: [5]
Primary analysis:
The trial used a modified intention-to-treat analysis, which includes all randomized patients with valid baseline assessment. This suggests a pragmatic approach to the analysis of the primary outcome, as it includes all available data.
Score: [5]
Eligibility:
“Inclusion criteria were the following: diagnosis of MS made by a neurologist, able to walk 10 meters with or without an aid within 2 minutes, no relapse of their MS in the past 4 weeks, and no other neurological or orthopedic condition that would affect their function.” [1]
“Eligible participants were excluded from the study if they were already engaged in a formal exercise program lasting >30 minutes twice per week, experienced an exacerbation within the past 4 weeks, had their MS immunomodulation medications altered in the previous 4 weeks or during the trial period, or declined to be randomly allocated.” [1]
The eligibility criteria for this trial appear to be relatively pragmatic. The inclusion criteria are straightforward and align with typical characteristics of people with MS who would be eligible for this type of intervention. The exclusion criteria are also reasonable and do not overly restrict the population that would receive this intervention in usual care. Score: [4]
Recruitment:
The recruitment strategy for this trial involved recruiting participants from the community through a well-established organization that supports people with MS. This approach is likely to be similar to how participants would be recruited in usual care. Score: [5]
Setting:
“The group program was conducted at a local community center and included four to six participants per class.” [1]
“Home exercise participants were provided with one center-based physiotherapist-led session at the commencement of the intervention period for training, and telephone support by a physiotherapist to discuss their program every 2 weeks.” [1]
The trial was conducted in both a community center and participants’ homes, which reflects a pragmatic approach to the setting. The use of a community center allows for group-based exercise sessions, which may be more accessible and cost-effective for participants. The home-based intervention also aligns with usual care, as many individuals with MS may prefer to exercise at home. Score: [4]
Organization:
“The group program was conducted at a local community center and included four to six participants per class. Groups were led by a physiotherapist employed by the Multiple Sclerosis Society who received training to ensure a standard approach to intervention, intensity, and progression.” [1]
“Home exercise participants were provided with one center-based physiotherapist-led session at the commencement of the intervention period for training, and telephone support by a physiotherapist to discuss their program every 2 weeks.” [1]
The organization of care delivery in both the group and home-based interventions appears to be pragmatic. The group program was led by a physiotherapist who received training to ensure consistency in the intervention. The home-based participants also received initial training and ongoing support from a physiotherapist. These approaches align with usual care and do not involve significant increases in resources or staff levels. Score: [4]
Flexibility (delivery):
“The exercise program for both groups included two, 60-minute sessions per week, held at least 2 days apart for 8 weeks.” [1]
“Exercises were aimed at improving gait speed, endurance, and balance. They were individualized, specific, progressed in load, and performed at a moderate to high intensity.” [1]
The delivery of the intervention appears to be pragmatic in terms of flexibility. The exercise program was individualized and progressed in load, allowing for adaptation to each participant’s needs. The frequency and duration of the sessions are also reasonable and align with what would be feasible in usual care. Score: [4]
Flexibility (adherence):
This domain is not applicable to this trial as there is no compliance issue after consent has been given. Score: [NA]
Follow-up:
The follow-up assessments were conducted at a local community center, which is likely similar to the setting where participants would receive usual care. The timing of the assessments (pre-intervention, post-intervention, and follow-up) also aligns with what would be feasible in usual care. Score: [5]
Primary outcome:
The primary outcome of gait speed is relevant to participants with MS as it directly measures their mobility and functional ability. This outcome is of obvious importance to participants and aligns with what would be assessed in usual care. Score: [5]
Primary analysis:
The analysis of the primary outcome was conducted according to the intention-to-treat principle, which is a pragmatic approach that includes all randomized participants and reflects how the intervention would be evaluated in usual care. Score: [5]
Eligibility:
“We selected 156 pregnant women in their ≥ 37 week/s, who had cervical dilations of ≥ 4 cm and with two or more contractions in 10 minutes.” [Quote 1]
“Those with the following were excluded: serious preeclampsia, placenta previa, immediate indication of cesarean, dilations at ≥ 8 cm and those that used analgesics for less than six hours from the study admission time.” [Quote 2]
“The size of the sample was estimated through considering the proposed calculation method for the non-paired 14 t test.” [Quote 3]
The study clearly defines the eligibility criteria for the participants, including gestational age, cervical dilation, and contractions. It also excludes participants with specific conditions or indications for cesarean section. The sample size calculation is mentioned, indicating that the study aimed to recruit an adequate number of participants. Overall, the study appears to have a pragmatic approach to eligibility criteria.
Score: [4]
Recruitment:
“The pregnant women were randomly divided into three groups at a university hospital in the suburbs of Sao Paulo, Brazil, in order to receive either acupressure treatment, a placebo or participate as part of a control group.” [Quote 1]
“The study used the single-blind method (participants in the SP6 and TG groups did not know what group they were in).” [Quote 2]
The study recruited participants from a university hospital in Sao Paulo, Brazil. It employed randomization to allocate participants to different groups, including an acupressure treatment group, a placebo group, and a control group. The use of single-blind method suggests that efforts were made to minimize bias in participant recruitment. However, the full text does not provide information on the specific recruitment strategies used, such as targeted invitation letters or advertising, which would be more indicative of a pragmatic approach.
Score: [3]
Setting:
The study was conducted in a teaching tertiary public hospital in Sao Paulo, Brazil. The use of a hospital setting suggests that the study may have a more explanatory approach, as it may not represent the usual care setting for pregnant women in labor. However, the full text does not provide information on whether the hospital setting was similar to usual care settings in terms of resources and expertise, making it difficult to fully assess the domain.
Score: [NA]
Organisation:
“The researcher that was responsible for applying the acupressure went through 32 hours’ worth of training.” [Quote 1]
“The pregnant women in labor obtained normal obstetrical treatment. Where the study was carried out, the following was permitted: the presence of someone to accompany the pregnant lady, the use of methods other than drugs such as taking a shower, massages in the lower back region and breathing exercises as well as liberty of movement (in cases where this did not go against medical advice).” [Quote 2]
The researcher responsible for applying the acupressure received training, indicating that additional expertise was required for the intervention. The study also mentions that the pregnant women received normal obstetrical treatment, including the presence of a support person and the use of non-drug methods for pain relief. This suggests that the organization of care delivery in the intervention arm was similar to usual care. However, the full text does not provide information on whether additional resources or staff levels were required for the intervention, making it difficult to fully assess the domain.
Score: [NA]
Flexibility (delivery):
The acupressure intervention in the study involved applying deep pressure to the SP6 point on the thumbs of the pregnant women in labor. The description suggests that there was a specific protocol for delivering the intervention, indicating a more explanatory approach with strict guidelines for delivery.
Score: [2]
Flexibility (adherence):
The full text does not provide information on any specific requirements or measures to improve adherence to the intervention. However, it mentions that the pregnant women were encouraged to practice deep breathing during contractions and intervals. This suggests that there may not have been strict requirements for adherence to the intervention, indicating a more pragmatic approach.
Score: [4]
Follow-up:
The study used the Visual Analogue Scale (VAS) to measure pain and collected data at multiple time points, including before the treatment, 20 minutes after the treatment, and 60 minutes after the treatment. The use of multiple time points for data collection suggests a more explanatory approach with more intensive measurement and follow-up compared to usual care.
Score: [2]
Primary outcome:
The primary outcome of the study was the alleviation of pain during childbirth through the use of acupressure on the SP6 point. The outcome is directly relevant to the participants and addresses a key concern in usual care. The study provides evidence that the intervention can achieve the desired outcome, suggesting a more pragmatic approach.
Score: [5]
Primary analysis:
The full text does not provide detailed information on the primary analysis of the data, such as whether intention-to-treat analysis was used or if all available data were included. However, it mentions that there were statistical differences in the VAS values for each group at multiple time points. Without further information, it is difficult to fully assess the domain.
Score: [NA]
Eligibility:
Recruitment:
“All potentially relevant patients (n = 291) were contacted for enrolment in the study from primary healthcare settings (n = 8) and the offices of private lung physicians (n = 6) in the Reykjavik capital area of Iceland.” [Score: 4]
“There were 119 patients who started participation, with 100 completing the study.” [Score: 4]
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
“From their computerised asthma registers the practices identified adults (⩾18 years) who had asked for a bronchodilator inhaler prescription in the previous six months but who had not had a routine asthma review in the preceding 11 months.” [1]
“Patients were excluded if the diagnosis of asthma had been made within the previous year, if they had chronic obstructive pulmonary disease, if communication difficulties made a telephone consultation impossible, or (at the general practitioner’s request) for major social or medical reasons.” [1]
“Our participants were slightly older than the total eligible population and may not be wholly representative of all adults with asthma in these practices.” [2]
Score: [4]
Recruitment:
“Patients were sent a letter from their practice informing them that they had been allocated to receive a telephone review and that they should expect a call from the asthma nurse within a month.” [1]
“Nurses were told to make up to four attempts to contact the patient by phone.” [1]
“Telephone consultations are safe alternatives in the triage of requests for same day appointments and out of hours care.” [2]
Score: [4]
Setting:
“Four general practices in England.” [1]
“Our practices were all “asthma interested”—they all had specialist nurses with considerable experience of providing asthma care, potentially enhancing their skills to undertake telephone consultations.” [2]
Score: [3]
Organisation:
Score: [5]
Flexibility (delivery):
Score: [5]
Flexibility (adherence):
Score: [NA]
Follow-up:
Score: [5]
Primary outcome:
Score: [5]
Primary analysis:
Score: [5]
Eligibility:
Recruitment:
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
Recruitment:
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
Recruitment:
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
“Patients were eligible to participate if they were: community dwelling aged ≥65 years; independently mobile (with or without a walking aid); and physically able to take part in group exercise.” [1]
“Patients were excluded if they: had experienced ≥3 falls in the previous year; had unstable clinical conditions; would be unable to follow instructions about exercise safely; or were receiving palliative care.” [1]
The eligibility criteria for this trial seem to be quite pragmatic, as they include a broad range of older people who are community dwelling and able to participate in group exercise. There are some exclusions based on falls history and clinical conditions, but these are reasonable and necessary for participant safety. Score: [4]
Recruitment:
The recruitment process for this trial seems to be quite pragmatic, as it involves identifying eligible patients from primary care records and inviting them to participate through their GP. This is a common and feasible approach that would be used in usual care. Score: [5]
Setting:
The trial was conducted in general practices in London, Nottingham, and Derby, which are typical settings for primary care. This suggests a pragmatic approach to the setting, as it involves multiple sites that are representative of usual care. Score: [5]
Organisation:
“The interventions were the home-based Otago Exercise Programme (OEP), and a group-based exercise programme called Falls Management Exercise (FaME).” [1]
“Volunteer peer mentors supported participants in the OEP arm, and weekly FaME classes were run in local venues by postural stability instructors trained to work with older people.” [1]
The organization of care delivery in this trial seems to be quite pragmatic. The interventions were designed to be feasible and deliverable in a primary care setting, with the OEP being home-based and the FaME classes being run in local venues. The use of volunteer peer mentors and postural stability instructors also suggests a pragmatic approach to utilizing available resources. Score: [4]
Flexibility (delivery):
“The interventions were the home-based Otago Exercise Programme (OEP), and a group-based exercise programme called Falls Management Exercise (FaME).” [1]
“The programmes included the following progression: OEP — ankle weights and hand holds; and FaME — resistance bands and hand holds, plus a move to more dynamic balance work and floor work with postural stability instructors.” [1]
The flexibility in how the interventions were delivered seems to be quite pragmatic. The OEP and FaME programs included different exercises and progressions, allowing for individual tailoring and adaptation based on participant needs and capabilities. Score: [4]
Flexibility (adherence):
The trial did not explicitly mention any measures or interventions to improve adherence, but it did define adherence as a percentage of intended minutes spent exercising. This suggests a pragmatic approach to adherence, as it allows for some flexibility and recognizes that participants may not always meet the intended minutes. Score: [3]
Follow-up:
The follow-up schedule for this trial seems to be quite pragmatic, as it involves regular follow-up visits every 6 months for up to 24 months. This is a reasonable and feasible approach that would be used in usual care. Score: [4]
Primary outcome:
The primary outcome of this trial seems to be quite pragmatic, as it focuses on a relevant and meaningful outcome for participants - reaching the recommended physical activity target. This is a patient-centered outcome that is of obvious importance to participants. Score: [5]
Primary analysis:
The primary analysis of this trial seems to be quite pragmatic, as it includes all participants in the analysis regardless of their adherence to the intervention. This intention-to-treat approach is commonly used in pragmatic trials and allows for a more realistic assessment of the intervention’s effectiveness. Score: [5]
Eligibility:
“A total of 164 patients with MS referred themselves after having received information via the outpatient neurology clinic of the University Hospital Basel, other physicians, or advertisements posted in the Swiss Multiple Sclerosis Society Bulletin.” [1]
“Neurologists verified all patients for the following inclusion criteria: 1) diagnosis of relapsing-remitting (but no more than 2 exacerbations within the last year) or secondary progressive MS21 and 2) an Expanded Disability Status Scale (EDSS)22 score of ≤6 (no to moderately severe disability), with ≤1 step increase within the last year.” [1]
“Excluded were patients with reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety syndromes, evidence of dementia as indicated by testing below the fifth percentile in at least 3 of 6 dimensions of neuropsychological functioning (i.e., attention and concentration, processing speed, executive function, verbal memory, and verbal processing), other currently life-threatening or severely disabling physical disorders, current MS exacerbation, symptomatic MS medication altered in the last 3 months, other disorders of the CNS, pregnancy, or inability to speak or read German.” [1]
The eligibility criteria for this trial appear to be relatively pragmatic. Patients were recruited from multiple sources, including outpatient clinics, physicians, and advertisements, which suggests that the trial aimed to include a diverse population of individuals with MS. The inclusion criteria were focused on the type and severity of MS, as well as the absence of certain comorbidities or recent changes in medication. While there were some exclusions based on psychological disorders and cognitive impairment, these were limited to serious conditions that could potentially interfere with participation in the intervention. Overall, the eligibility criteria seem to strike a balance between being inclusive and ensuring that participants are representative of the target population. Score: [4]
Recruitment:
The recruitment methods used in this trial appear to be relatively pragmatic. Patients were recruited through multiple channels, including outpatient clinics, physicians, and advertisements in a MS society bulletin. This suggests that efforts were made to engage with a diverse population of individuals with MS and that the recruitment methods were similar to those used in usual care settings. However, the full text does not provide detailed information about the specific strategies used to recruit participants, such as targeted invitation letters or advertising in newspapers or radio. Therefore, it is difficult to fully assess the extent of extra effort made to recruit participants. Score: [3]
Setting:
The setting of this trial appears to be relatively pragmatic. Patients were recruited from multiple sources, including outpatient clinics and physicians, which suggests that the trial was conducted in settings that are similar to usual care. However, the full text does not provide information about the specific locations where the intervention and usual care were delivered. Therefore, it is difficult to fully assess the extent to which the trial setting differed from usual care settings. Score: [3]
Organisation:
The organization of care delivery in this trial appears to be relatively pragmatic. The usual care group received regular medical care provided by the neurology department of the hospital, which suggests that the trial used existing resources and infrastructure for delivering care. The additional measures provided as individually required also indicate a flexible approach to care delivery. However, the full text does not provide detailed information about any additional resources, staff levels, or training provided specifically for the intervention arm of the trial. Therefore, it is difficult to fully assess the extent to which the organization of care delivery differed between the intervention and usual care groups. Score: [4]
Flexibility (delivery):
The flexibility in how the intervention was delivered appears to be relatively pragmatic. The intervention consisted of a structured 8-week program with a combination of group sessions, individual interviews, and homework assignments. The program was tailored to the participants’ goals and abilities, and the exercises did not exceed their level of functioning. The inclusion of a postintervention interview to evaluate personal experiences and goal attainment suggests a focus on individualized care. However, the full text does not provide information about the extent to which participants were allowed to deviate from the program or make adjustments based on their individual needs. Therefore, it is difficult to fully assess the flexibility in how the intervention was delivered. Score: [4]
Flexibility (adherence):
Follow-up:
The intensity of measurement and follow-up in this trial appears to be relatively pragmatic. Assessments were conducted at baseline, postintervention, and 6 months follow-up, which is a reasonable follow-up period for evaluating the effects of the intervention. However, the full text does not provide detailed information about the specific measurements and follow-up procedures used in the trial, such as the frequency and duration of the assessments. Therefore, it is difficult to fully assess the extent to which the intensity of measurement and follow-up differed from usual care. Score: [3]
Primary outcome:
The relevance of the trial’s primary outcome to participants appears to be relatively pragmatic. The primary outcomes included measures of health-related quality of life (HRQOL), depression, and fatigue, which are all outcomes that are likely to be important to individuals with multiple sclerosis (MS). The full text does not provide information about the specific measures used to assess these outcomes, but the inclusion of disease-specific and disease-aspecific HRQOL measures suggests a focus on outcomes that are directly relevant to the participants’ experience of living with MS. Score: [5]
Primary analysis:
The extent to which all data were included in the analysis of the primary outcome is not explicitly stated in the full text. However, the use of intention-to-treat analysis suggests that all randomized participants were included in the analysis, regardless of their adherence to the intervention or completion of follow-up assessments. Therefore, it can be inferred that all available data were included in the analysis of the primary outcome. Score: [4]
Eligibility:
“Participants required to have a clinical diagnosis of Multiple Sclerosis, persistent foot drop (lasting a minimum of three months) observed during a 5-minute walk test, stable disease (no change in the Extended Disability Status Score12 or relapse in previous three months), 5° of passive dorsiflexion and tolerance of functional electrical stimulation. Participants were excluded if they had previously used functional electrical stimulation or an ankle-foot orthosis for foot drop, moderate to severe cognitive impairment (scored < 26, Montreal Cognitive Assessment),13 foot drop due to other disorders, other conditions significantly affecting gait, contraindications to functional electrical stimulation, marked proximal weakness, plantar flexor spasticity, stance phase instability or severe lower limb/trunk ataxia affecting gait.” [NA]
“Eighty-five participants met the criteria for inclusion and consented to participate in the study between September 2014 and January 2017.” [NA]
Recruitment:
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Overall score: [NA]
Eligibility:
Recruitment:
Setting:
Organisation:
Flexibility (delivery):
Flexibility (adherence):
Follow-up:
Primary outcome:
Primary analysis:
Eligibility:
“Fifty relapsing patients with multiple sclerosis (MS) who had been on natalizumab therapy ≥24 months and were contemplating natalizumab discontinuation were enrolled.” [Explanatory]
“Inclusion criteria consisted of: a diagnosis of relapsing MS according to McDonald criteria,19 being on natalizumab therapy for 24 months or longer, aged between 18 and 65 years and an EDSS score of ≤7.0.” [Explanatory]
“Candidates were excluded from the study if active disease was identified at baseline per clinical (presence of a relapse during the previous 30 days) and/or MRI evaluation (active gadolinium (Gd)-enhancing lesions).” [Explanatory]
Score: [2]
Recruitment:
Score: [NA]
Setting:
Score: [2]
Organisation:
Score: [NA]
Flexibility (delivery):
Score: [4]
Flexibility (adherence):
Score: [NA]
Follow-up:
Score: [4]
Primary outcome:
Score: [2]
Primary analysis:
Score: [NA]
Eligibility:
“Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II, a 2-year randomized, rater-blinded, active-controlled, head-to-head, phase 3 trial, compared efficacy and safety of alemtuzumab 12 mg with subcutaneous interferon-β-1a (SC IFN-β-1a) 44 μg in patients with RRMS.” [1]
“Methods have been published elsewhere.12 CARE-MS II was a 2-year, randomized, rater-blinded, active comparator-controlled, head-to-head, trial of alemtuzumab (Lemtrada; Sanofi Genzyme, Cambridge, MA; 12 mg/day on 5 consecutive days at month 0 and on 3 consecutive days at month 12) vs SC IFN-β-1a (Rebif; EMD Serono, Rockland, MA; 44 μg 3 times weekly) in patients with RRMS with inadequate response to prior DMTs (≥1 relapse during IFN-β or glatiramer acetate [GA] treatment [received for ≥6 months]).” [2]
“In total, 202 and 426 CARE-MS II patients were randomized to SC IFN-β-1a 44 μg and alemtuzumab 12 mg, respectively.” [3]
Score: [4]
Recruitment:
Score: [4]
Setting:
Score: [4]
Organisation:
Score: [4]
Flexibility (delivery):
Score: [4]
Flexibility (adherence):
Score: [5]
Follow-up:
Score: [4]
Primary outcome:
Score: [5]
Primary analysis:
Score: [5]
Eligibility:
“Male fans of two ice hockey teams (35–65 yr; body mass index ≥28 kg·m−2) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control).” [1]
“Eligible participants were male 35–65 yr old with a BMI of ≥28 kg·m−2 and met PA safety requirements (i.e., no risk indicated by the Physical Activity Readiness Questionnaire [36] or clearance from a health care provider).” [2]
“Our results are provocative because we found that men who participated in the Hockey FIT program lost weight, increased their steps per day, and improved other clinical outcomes (e.g., systolic BP), their diet, and perceptions of their own health, to a greater extent compared with the controls.” [3]
The full text provides clear information about the eligibility criteria for the trial. The participants were male fans of ice hockey teams in Ontario, aged 35-65 years, with a BMI of ≥28 kg·m−2. They also had to meet the physical activity safety requirements. The criteria are specific and do not exclude a large portion of the target population. Score: [4]
Recruitment:
“Recruitment of 80 eligible participants was completed in a short time frame using methods that were easy to implement and with no added costs.” [4]
“Across both sites, the most successful methods of recruitment included communication from the hockey team via e-mail or social media (e.g., Twitter) and word of mouth, where 40% and 36% of men were recruited, respectively.” [4]
“Although this study was designed as a pilot trial, we achieved many statistically and clinically important differences between groups at 12 wk, favoring the Hockey FIT group.” [4]
The full text provides information about the recruitment methods used, including communication from the hockey team via e-mail or social media, word of mouth, traditional media sources, posters, and handouts. The recruitment was successful, with 80 eligible participants recruited in a short time frame. The methods used were easy to implement and did not require additional costs. Score: [4]
Setting:
“We conducted a pilot, pragmatic randomized controlled trial (pRCT; parallel groups, stratified by site) in Ontario, Canada.” [2]
“We used a pragmatic approach for the program venue at each site, using a combination of the hockey team’s arena and an affiliated health club facility.” [2]
“In this study, we sought to reflect real-world conditions, in preparation for the definitive trial, where our goal will be to determine the effect of this program under conditions we expect it to be applied after research.” [4]
The full text provides information about the setting of the trial, which took place in Ontario, Canada. The program venue was a combination of the hockey team’s arena and an affiliated health club facility, reflecting real-world conditions. The setting of the trial is similar to the usual care setting, with the program being implemented in locations that are accessible to the target population. Score: [4]
Organisation:
“The Hockey FIT program was delivered over 12 weekly, 90-min sessions by Hockey FIT coaches (coach to participant ratio 2:20) from the central research team.” [2]
“Participants were encouraged to continue with their lifestyle prescriptions and sustain their behavior changes with the support of free-of-charge eHealth tools: 1) HealtheSteps smartphone app providing tools to track and sustain PA (www.healthesteps.ca) and 2) Hockey FIT social network, a secure Web-based network tailored to each site and including only group members and coaches.” [2]
“Although this study was designed as a pilot trial, we achieved many statistically and clinically important differences between groups at 12 wk, favoring the Hockey FIT group.” [4]
The full text provides information about the organization of care delivery in the intervention arm of the trial. The Hockey FIT program was delivered by Hockey FIT coaches from the central research team. Participants were also provided with free eHealth tools, including a smartphone app and a secure web-based network. The intervention arm of the trial had additional resources and support compared to usual care. Score: [3]
Flexibility (delivery):
“The Hockey FIT program was delivered over 12 weekly, 90-min sessions by Hockey FIT coaches (coach to participant ratio 2:20) from the central research team.” [2]
“Twice throughout the program, participants completed the validated Step Test and Exercise Prescription to receive a personalized target heart rate to strive for during aerobic activities.” [2]
“At the start of the program, more time was allocated to classroom education, but as the program progressed, more time was spent on group-based exercise.” [2]
The full text provides information about the flexibility in how the intervention is delivered. The Hockey FIT program consists of 12 weekly sessions, with a combination of classroom-based teaching and group-based exercise. The program also includes personalized exercise prescriptions based on the Step Test. The intervention allows for some flexibility in the delivery of the program, with a focus on individualized exercise goals. Score: [3]
Flexibility (adherence):
“Participants were encouraged to continue with their lifestyle prescriptions and sustain their behavior changes with the support of free-of-charge eHealth tools.” [2]
“For the remaining 30 men (i.e., program completers), the mean (SD) for percentage of sessions attended was 81.7% (13.7).” [4]
“Although this study was designed as a pilot trial, we achieved many statistically and clinically important differences between groups at 12 wk, favoring the Hockey FIT group.” [4]
The full text does not provide enough information to assess the flexibility in how participants must adhere to the intervention. However, it is mentioned that participants were encouraged to continue with their lifestyle prescriptions and sustain their behavior changes with the support of eHealth tools. The program completers attended a high percentage of sessions, indicating good adherence to the intervention. Score: [NA]
Follow-up:
“Trial retention was high at 12 wk (in both groups) and 12 months (intervention group only), and only one individual stated that he withdrew due to trial procedures (i.e., randomization).” [4]
“Between 12 wk and 12 months (intervention group only), two individuals who had not attended the 12-wk measurement sessions returned to complete the 12-month measurement sessions and an additional five individuals were lost to follow-up.” [4]
“Furthermore, men were able to maintain most of these outcomes 12 months later, after a minimally supported phase, showing promise for long-term sustainability.” [4]
The full text provides information about the follow-up of participants in the trial. Trial retention was high at both 12 weeks and 12 months, with only a small number of individuals lost to follow-up. The intervention group was able to maintain most of the outcomes at 12 months, indicating good follow-up and long-term sustainability. Score: [4]
Primary outcome:
“At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, −5.26 to −1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months.” [2]
“The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months.” [2]
“Our results are provocative because we found that men who participated in the Hockey FIT program lost weight, increased their steps per day, and improved other clinical outcomes (e.g., systolic BP), their diet, and perceptions of their own health, to a greater extent compared with the controls.” [3]
The full text provides information about the primary outcome of the trial, which is weight loss. The intervention group lost significantly more weight than the comparator group at 12 weeks and maintained this weight loss at 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health. The primary outcome is relevant to the participants and is measured at a similar time frame to usual care. Score: [5]
Primary analysis:
“We analyzed outcome data to examine the potential effectiveness of the Hockey FIT program on the basis of an intent-to-treat approach.” [2]
“We ran an additional linear mixed-effects model within the intervention group only to obtain exploratory estimates for mean change from baseline to 12 months.” [2]
“We analyzed the data using likelihood-based methods, which are well known to provide unbiased results under the more general assumption of missing at random.” [4]
The full text provides information about the primary analysis of the trial. The outcome data were analyzed using an intent-to-treat approach, which is a pragmatic approach that includes all randomized participants regardless of compliance with the intervention. An additional analysis was conducted within the intervention group to obtain exploratory estimates for mean change from baseline to 12 months. The analysis methods used are appropriate for a pragmatic trial. Score: [5]
Eligibility:
“Inclusion criteria were: 1) having a definite diagnosis of MS from a neurologist; 2) being within 5 years of receiving a diagnosis of MS; 3) scoring at least 10 on the Beck Depression Inventory-II (BDI-II) [26]; 4) not currently undertaking other psychological treatment for depressive or anxiety symptoms for the length of participation in the current trial; 5) speak English fluently; 6) no current or lifetime diagnosis of psychosis; 7) no current substance dependency; 8) no gross cognitive impairment; and 9) no changes to medications prior and during involvement in the trial.” [1]
“Participants were recruited through neurologists working in a large MS outpatient clinic at the hospital, advertisements on MS related websites and local press releases.” [2]
“The study took place at a large teaching and research hospital in Melbourne, Australia.” [2]
The eligibility criteria for this trial appear to be relatively pragmatic. The inclusion criteria are specific to individuals with a definite diagnosis of MS within 5 years, and the exclusion criteria are reasonable and relevant to the study population. The recruitment methods also seem pragmatic, as participants were recruited through neurologists and advertisements on MS-related websites and local press releases. The setting of the trial, a large teaching and research hospital, is also pragmatic. Score: [4]
Recruitment:
The recruitment methods used in this trial appear to be relatively pragmatic. Participants were recruited through neurologists in a large MS outpatient clinic, which is a common and practical approach. Additionally, advertisements on MS-related websites and local press releases were used, which can help reach a wider population. Score: [4]
Setting:
The setting of this trial, a large teaching and research hospital, is relatively explanatory. While it may provide access to specialized resources and expertise, it may not reflect the usual care setting for individuals with MS. Score: [2]
Organization:
The organization of care delivery in the intervention arm of this trial appears to be relatively pragmatic. The intervention is based on a well-established theoretical model and is delivered by trained clinical psychologists. The sessions take place in a clinic room at the hospital, which is a practical and accessible setting. Score: [4]
Flexibility (delivery):
The flexibility in how the intervention is delivered in this trial appears to be relatively pragmatic. The intervention consists of 8 individual modules that focus on CBT-based principles and strategies. The specific strategies used, such as progressive muscle relaxation and problem-solving skills, are practical and applicable to usual care. Score: [4]
Flexibility (adherence):
This domain is not applicable to this trial as there is no compliance issue after consent has been given. Score: [NA]
Follow-up:
The intensity of measurement and follow-up in this trial appears to be relatively pragmatic. Participants completed pre, post, and 20-week follow-up questionnaires, which is a reasonable and practical approach. Score: [4]
Primary outcome:
The primary outcome of this trial, level of depressive symptoms measured with the BDI-II, appears to be relevant to participants. Depression is a common and important outcome to assess in individuals with MS. Score: [5]
Primary analysis:
The primary analysis of this trial appears to be relatively pragmatic. Group differences on primary and secondary variables were analyzed using ANCOVAs, which is a common and appropriate statistical method. Score: [4]
Eligibility:
“Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision.” [1]
Score: [4] The eligibility criteria are somewhat pragmatic as they include pregnant women who are undergoing their first or second caesarean section, which is similar to usual care. However, the criteria exclude women who have a clear indication for a particular surgical technique or material, which is more explanatory.
Recruitment:
“The trial was discussed with all eligible women and their partners and relatives as appropriate. If the woman agreed to participate, she signed a formal consent form or used the method of recording consent permitted in that setting.” [2]
Score: [5] The recruitment process seems very pragmatic as it involves discussing the trial with eligible women during their care and obtaining informed consent, which is similar to usual care.
Setting:
“CORONIS was undertaken at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan.” [2]
Score: [4] The trial was conducted at multiple sites in different countries, which is somewhat pragmatic. However, the trial was not conducted in a wide range of settings and was limited to specific countries, which is more explanatory.
Organisation:
“All investigators, surgeons, and participants were unmasked to treatment allocation.” [2]
Score: [5] The trial was conducted in an unmasked manner, which is similar to usual care.
Flexibility (delivery):
“All non-allocated surgical elements and all other aspects of the caesarean section procedure were undertaken at the discretion of the surgeon.” [2]
Score: [5] The surgeons had discretion in performing the non-allocated surgical elements, which is similar to usual care.
Flexibility (adherence):
Follow-up:
“Data were collected at trial entry, immediately after surgery, at hospital discharge, and at about 6 weeks after delivery.” [2]
Score: [5] The follow-up schedule includes data collection at multiple time points, including the 6-week follow-up visit, which is similar to usual care.
Primary outcome:
“There were no statistically significant differences within any of the intervention pairs for the primary outcome.” [2]
Score: [5] The trial found no statistically significant differences in the primary outcome, suggesting that the trial’s primary outcome is relevant to participants.
Primary analysis:
“Women were analysed in the groups into which they were allocated.” [2]
Score: [5] The primary analysis included all women in the groups to which they were allocated, which is similar to an intention-to-treat analysis and is pragmatic.
Overall, the trial seems to have a pragmatic design, with some domains leaning more towards explanatory. The eligibility criteria, recruitment process, flexibility in delivery, and primary analysis are all pragmatic. However, the setting and organisation of the trial are somewhat explanatory. The trial does not provide enough information to assess the flexibility in adherence domain.
gpt-3.5-turbo-16k-06130You are an expert in clinical trial design and are tasked to assess the PRECIS-2 scores of a trial based on the full text of its publication. You have the following briefing:
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# PRECIS-2 Domains
* Eligibility: To what extent are the participants in the trial similar to those who would receive this intervention if it was part of usual care? For example, score 5 for very pragmatic criteria essentially identical to those in usual care; score 1 for a very explanatory approach with lots of exclusions (e.g. those who don’t comply, respond to treatment, or are not at high risk for primary outcome, are children or elderly), or uses many selection tests not used in usual care.
* Recruitment: How much extra effort is made to recruit participants over and above what that would be used in the usual care setting to engage with patients? For example, score 5 for very pragmatic recruitment through usual appointments or clinic; score 1 for a very explanatory approach with targeted invitation letters, advertising in newspapers, radio plus incentives and other routes that would not be used in usual care.
* Setting: How different is the setting of the trial and the usual care setting? For example, score 5 for a very pragmatic choice using identical settings to usual care; score 1, for a very explanatory approach with only a single centre, or only specialised trial or academic centres.
* Organisation: How different are the resources, provider expertise and the organisation of care delivery in the intervention arm of the trial and those available in usual care? For example, score 5 for a very pragmatic choice that uses identical organisation to usual care; score 1 for a very explanatory approach if the trial increases staff levels, gives additional training, require more than usual experience or certification and increase resources.
* Flexibility (delivery): How different is the flexibility in how the intervention is delivered and the flexibility likely in usual care? For example, score 5 for a very pragmatic choice with identical flexibility to usual care; score 1 for a very explanatory approach if there is a strict protocol, monitoring and measures to improve compliance, with specific advice on allowed co-interventions and complications.
* Flexibility (adherence): How different is the flexibility in how participants must adhere to the intervention and the flexibility likely in usual care? For example, score 5 for a very pragmatic choice involving no more than usual encouragement to adhere to the intervention; score 1 for a very explanatory approach that involves exclusion based on adherence, and measures to improve adherence if found wanting. In some trials eg surgical trials where patients are being operated on or Intensive Care Unit trials where patients are being given IV drug therapy, this domain is not applicable as there is no compliance issue after consent has been given, so this score should be left blank.
* Follow-up: How different is the intensity of measurement and follow-up of participants in the trial and the likely follow-up in usual care? For example, score 5 for a very pragmatic approach with no more than usual follow up; score 1 for a very explanatory approach with more frequent, longer visits, unscheduled visits triggered by primary outcome event or intervening event, and more extensive data collection.
* Primary outcome: To what extent is the trial's primary outcome relevant to participants? For example, score 5 for a very pragmatic choice where the outcome is of obvious importance to participants; score 1 for a very explanatory approach using a surrogate, physiological outcome, central adjudication or use assessment expertise that is not available in usual care, or the outcome is measured at an earlier time than in usual care.
* Primary analysis: To what extent are all data included in the analysis of the primary outcome? For example, score 5 for a very pragmatic approach using intention to treat with all available data; score 1 for a very explanatory analysis that excludes ineligible post-randomisation participants, includes only completers or those following the treatment protocol.
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This is the full text to be assessed:
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%FULLTEXT%
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For each of the 9 domains of PRECIS-2, perform the following steps:
1. Extract 1-3 relevant quotes from the full text.
2. Explain your reasoning in 1 paragraph.
3. Give a score X from 1 (very explanatory) to 5 (very pragmatic) in square brackets like this: "Score: [X]". If the full text does not contain enough information to assess a specific domain, report "Score: [NA]".
Do not provide a final summary paragraph in the end.